Pluristem Therapeutics Announces Interim Results from PLX-PAD Clinical Trials
Data Suggests PLX-PAD is Safe and Potentially Efficacious
HAIFA, Israel--(BUSINESS WIRE)--Jan 11, 2010 - Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced interim results from their Phase I clinical trials utilizing their placenta derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). Data suggested that PLX-PAD is safe and potentially efficacious.
Nine patients, representing one-third of the patients needed to complete the Phase I dose-escalating studies in the U.S. and Germany, have been dosed with PLX-PAD. Patients experienced no significant unfavorable effects related to PLX-PAD administration. Three of the nine patients dosed completed their three-month follow up and the data from those patients demonstrated a trend towards efficacy with a reduction in their Rutherford Category, a measure of the severity of their limb ischemia.
“The interim results are in line with the data from the first patient treated with PLX-PAD,” said Professor Doctor André Schmidt-Lucke, Director of the Franziskus-Krankenhaus Institute of Berlin, Germany. “We are encouraged by the consistency of the data and believe that PLX-PAD may be an effective treatment for CLI.”
Zami Aberman, chairman and CEO of Pluristem, added, “The interim results are a significant milestone for Pluristem as we advance in our Phase I clinical trials to further test the safety and potential efficacy of PLX-PAD.”
Pluristem is a clinical stage biotechnology company with proprietary technology for the development and manufacturing of standardized cell therapies derived from the human placenta. Pluristem's patented and scalable PLX (PLacental eXpanded) cell product candidates are developed as readily available for the treatment of critical limb ischemia (CLI) and other diseases.
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Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, statements about the potential effectiveness, safety and efficacy of PLX-PAD are forward-looking statements. These forward-looking statements are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching our clinical trials; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
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Contact: Pluristem Therapeutics Inc.
William Prather RPh, MD
Sr. VP Corporate Development
+ 1 212-845-4235
Posted: January 2010